Last week, Sandoz announced the resubmission of its Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim). The resubmission is to address an FDA complete response letter that Sandoz received in June 2016. According to the press release, the resubmission includes new data from a pivotal pharmacokinetics/pharmacodynamics study. The study compared: (1) Sandoz’s pegfilgrastim with US-sourced reference pegfilgrastim; (2) Sandoz’s pegfilgrastim with EU-sourced reference pegfilgrastim; and (3) US-sourced reference pegfilgrastim with EU-sourced reference pegfilgrastim.
Last November, the European Commission approved Sandoz’s pegfilgrastim biosimilar (Ziextenzo®), indicated “to reduce duration of neutropenia/incidence of febrile neutropenia, some of the most serious side effects of chemotherapy.”